CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma

a study on Sarcoma Myxofibrosarcoma Solid Tumor

Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Brian Schulte, MD (ucsf)
Headshot of Brian Schulte
Brian Schulte

Description

Summary

The objective of this study is to assess the safety and efficacy of mecbotamab vedotin (BA3011) in solid tumors.

Official Title

A Phase 1/2 Dose Escalation and Dose Expansion Study of Mecbotamab Vedotin (BA3011) Alone and in Combination With Nivolumab in Adult and Adolescent Patients 12 Years and Older With Advanced Solid Tumors

Details

This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of mecbotamab vedotin (BA3011), a conditionally active biologic (CAB) AXL-targeted antibody drug conjugate (CAB-AXL-ADC) in patients with advanced solid tumors.

Phase 1 of this study will consist of a dose escalation phase (enrollment complete as of Oct 2019) and a dose expansion phase (enrollment complete as of Jan 2024).

Phase 2 will consist of two parts. Part 1 is designed to evaluate mecbotamab vedotin alone and with nivolumab in patients with various types of advanced sarcomas (enrollment complete as of Jan 2024). Part 2 will evaluate the safety and efficacy of mecbotamab vedotin in patients with undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS).

Keywords

Undifferentiated Pleomorphic Sarcoma, Myxofibrosarcoma, late stage, stage 3, stage 4, cancer, Sarcoma, Malignant Fibrous Histiocytoma, Immune Checkpoint Inhibitors, CAB-AXL-ADC, PD-1 inhibitor

Eligibility

You can join if…

Open to people ages 12 years and up

  • Patients must have measurable disease.
  • Age ≥ 12 years (Phase 2)
  • Adequate renal function
  • Adequate liver function
  • Adequate hematological function
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy of at least three months.

You CAN'T join if...

  • Patients must not have clinically significant cardiac disease.
  • Patients must not have known non-controlled CNS metastasis.
  • Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study.
  • Patients must not have had major surgery within 4 weeks before first BA3011 administration.
  • Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
  • Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
  • Patients must not be women who are pregnant or breast feeding.

Locations

  • UCSF Medical Center - Cancer Immunotherapy Clinic (CIC) accepting new patients
    San Francisco California 94158 United States
  • Precision NextGen Oncology accepting new patients
    Los Angeles California 90212 United States
  • Tower Hematology Oncology Medical Group completed
    Los Angeles California 90048 United States
  • Children's Hospital Los Angeles completed
    Los Angeles California 90027 United States
  • USC Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States

Lead Scientist at University of California Health

  • Brian Schulte, MD (ucsf)
    Dr. Brian Schulte is a hematologist-oncologist who cares for patients with sarcomas, rare cancers that develop in connective tissues (such as bone, muscle or cartilage) and can affect people of all ages. Working as part of a multidisciplinary team, he strives to ensure patients receive the best possible comprehensive care.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BioAtla, Inc.
ID
NCT03425279
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 300 study participants
Last Updated